Food, drugs, devices › Owens & Minor Distribution, Inc.
Device recall: Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Owens & Minor Distribution, Inc. (Mechanicsville, VA) initiated this device recall on 31 Oct 2022; FDA lists 1 product record under event 91122, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Owens & Minor Distribution, Inc. has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Owens & Minor Distribution, Inc., Mechanicsville, VA.
Reason for recall
"Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection"
Distribution
"IL, IN, WV"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0343-2023 | Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 | 72 cases (2160 pouches) | Class II | Ongoing | 7 Dec 2022 |
Context
Other enforcement events for Owens & Minor Distribution, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Jan 2023 | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47 | Device | Class III | 1 |
| 31 Oct 2016 | Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 L | Device | Class II | 1 |
| 17 Nov 2015 | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers | Device | Class II | 3 |
| 25 Jun 2014 | MediChoice Dual-Release Folding Walker with 5" wheel | Device | Class II | 1 |
| 26 Mar 2013 | MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Produc | Device | Class II | 1 |
All 6 events for Owens & Minor Distribution, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "IL, IN, WV"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.